[News] Life Sciences & Healthcare

[News] Life Sciences & Healthcare

Anvisa publishes a new regulation for Software as Medical Device

Anvisa publishes a new regulation for Software as Medical Device

ANVISA’s (the Brazilian Health Regulatory Agency) Board of Directors approved a regulation for software as a Medical Device – SaMD, which will be effective from July 1st, 2022.

RDC 657/2022 results from Public Consultation 1,035/2021, which received over 440 contributions – 22 fully approved and 68 partially approved.

Previously, the regulation of SaMD was set forth by the combination of general MD regulations, such as RDC 185/2001, RDC 56/2001, RDC 40/2015, and Technical Note 04/2012. RDC 185, which dates back to 2001, sets forth general requirements for health products, including SaMD. In other words, Anvisa already required these products to be duly authorized before being launched on the market.

Conversely, Anvisa’s Technical Note 04/2012 provided specific guidelines for software such as medical devices. However, today’s new regulation complements RDC 185/2001[1], so software developers should comply with the general provisions.

prior regulations included requirements that software developers could not comply with. Since they aimed at tangible goods (not entailing intangible/virtual goods), some provisions could not apply to a SaMD – for example, using tags, labels, or printed leaflets when selling happens over the internet or mobile stores (“Apps“). On the other hand, certain information deemed necessary for monitoring the sanitary aspects of software (such as how they are updated) was not covered adequately in the mentioned regulations.

The new regulation brings the Brazilian market in line with recommendations from the International Medical Device Regulators Forum (IMDRF) – which Brazil is part of, along with the European Union, the United States, Canada, and Australia.

Critical aspects of the new regulation are highlighted below:

General definitions and requirements

RDC 657/2022 defines SaMD as a system for medical, dental, or laboratory use or applications intended for prevention, diagnosis, treatment, rehabilitation, or contraception. It must have no pharmacological, immunological, or metabolic effect on humans.

The SaMD is defined as a medical device, including if linked to in vitro diagnosis, provided it is intended for one or more of the above purposes and not part of any medical device hardware. Software licensed under subscription or centrally hosted software (Software as a Service) also meets this definition.

However, the definition of SaMD does not include any software:

(I) For well-being (software that encourages healthy activities, physical exercise that is not intended for prevention, diagnosis, treatment, rehabilitation, or contraception);
(II) Listed by ANVISA as a non-regulated product;
(III) Used solely for health services providers’ administrative or financial management;
(IV) That process demographic and epidemiological medical data, without any clinical, diagnostic, or therapeutic purpose; and
(V)  Linked to medical devices has already been regularized.

SaMD user instructions and labeling requirements

According to RDC 657/2022, SaMD user instructions and labels must comply with RDC 185/2001 and  RDC 431/2020. They must also include the following content:

(I) Procedures for updating SaMDs;

(II) Minimum hardware and software requirements;

(III) Information on how the software operates, including generic descriptions of the algorithms, routines, and formulas used for clinical processing (prevention, diagnosis, treatment, rehabilitation, or contraception) and their applicable clinical associations;

(IV) Mandatory alerts and warnings;

(V) Interoperability specifications, indicating software, hardware, and technological environment compatibility and incompatibility;

(VI) Cybersecurity information.

Companies are not required to provide physical labels and user instructions for software distributed over the internet. Furthermore, SaMD leaflets should preferably be in Portuguese.

Changes after SaMD approvals

RDC 657/2022 sets forth that any software should be resubmitted for approval or updates if:

(I) New clinical features are added, or the software indicates different forms of clinical use;

(II) Significant changes are made to the software’s clinical features, safety, and efficacy;

(III) The software is intended for purposes other than those previously determined;

(IV) There are changes to the software’s visual identity that no longer make it recognizable from the images submitted to Anvisa.

Minor changes that do not alter the visual identity of the software do not require Anvisa’s post-marketing authorization – as long as they have no impact on the SaMD’s indicated use, efficiency, or patient safety.

Last but not least, approval procedures for SaMD in regulations established before the new rule must be adjusted or complemented in line with it in the acts of its future amendments.

For further information on SaMD, please do not hesitate to contact our team via e-mail: lifesciences@soutocorrea.com.br.


[1] RDC No. 657/2022 is also complementary to RDC No. 36/2015; RDC No. 40/2015; RDC No. 15/2014; RDC No. 431/2020; RDC No. 546/2001; RDC No. 340/2020; RDC No. 551/2021; and RDC No. 67/2009.

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